The CMC Program Lead supports the development and execution of the CMC strategy for Alentis pipeline products, ensuring that CMC activities are aligned with overall program objectives and clinical demand. The role oversees outsourced CMC activities across the product lifecycle, from cell line development and banking through process, formulation and analytical development, to drug substance and drug product manufacturing and release. Additionally, the CMC Program Lead works closely with the Regulatory function to prepare the CMC documentation required for regulatory submissions of the assigned biological products.

Tasks

Lead outsourced drug substance and drug product development in line with program objectives; work cross-functionally to evaluate product formats and support the development of new pipeline products.
Review and approve process, formulation and analytical development reports, master and executed batch records, change controls and deviations; maintain complete, accurate and inspection-ready CMC documentation and quality records.
Maintain manufacturing and supply plans as program evolves, and coordinate release documentation with Clinical Supply and Quality Assurance to ensure timely availability of toxicology and clinical materials.
Track stability data and support shelf-life extensions with internal teams and external partners.
Manage CMC project timelines, budgets and vendor contracts, track expenditure, update forecasts and approve invoices against agreed scope and completed work.
Represent CMC in cross-functional teams, communicate plans and progress, and organize technical meetings with associated agendas, minutes and follow-up of actions and decisions.
Identify, assess and mitigate quality, operational and organizational risks; escalate significant issues to the line manager.
Ensure GMP compliance and delivery to agreed quality standards for biopharmaceutical manufacturing for human use, including required records and approvals.
Prepare and review CMC sections of clinical trial applications and regulatory responses with the CMC Regulatory functions.

Requirements

PhD in Biology, Biotechnology, Pharmacy, Pharmaceutical Sciences or a related discipline.
At least 7+ years of relevant experience in the CMC development and management of biological products; experience with antibody drug conjugates (ADCs) is an asset.
Strong knowledge of GMP manufacturing and CMC regulatory requirements for biopharmaceuticals.
Hands on experience authoring or reviewing regulatory CMC documentation for biopharmaceuticals is an asset.
Excellent planning and organizational skills, with the ability to manage multiple priorities and adapt plans according to the program lifecycle.
Excellent written, verbal and technical communication skills, with the ability to communicate effectively across functions and with external partners.
Rigorous and detail-oriented, with the ability to maintain accurate, complete and inspection-ready documentation.
Open-minded, adaptable and proactive, with a hands-on and collaborative approach suited to a fast-paced, multicultural biotechnology environment.
Fluent in written and spoken English; additional languages are a plus.
Proficiency in Microsoft Office, including strong Excel skills for data review and analysis.
Workplace: on site in Allschwil with up to 2 days home office.
Candidate needs to hold a Swiss work permit or be an EU citizen eligible to work in Switzerland.

Contact

Doris Fink
Recruiter
Alentis Therapeutics AG

(Senior) Manager, CMC Program Lead

Tasks

Requirements

Contact